Smoking, Smoking Cessation
Conditions
Keywords
smoking, smoking cessation, nicotine replacement therapy
Brief summary
A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions: 1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or 2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT). This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period. Our specific hypotheses are as follows: Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up. Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.
Interventions
OTHERPractice Quit Attempt plus nicotine lozenge
nicotine lozenge, 2 mg or 4 mg
BEHAVIORALPractice Quit Attempt only
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current cigarette smoker of at least 10 cigarettes per day * Interested in quitting at some time * Not currently interested in quitting smoking * Access to telephone (home or work) for 6 month study period
Exclusion criteria
* Monthly cigar, pipe, or smokeless tobacco use * Current pregnancy or breastfeeding * Recent cardiovascular distress * Phenylketonuria (PKU) * Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | From study enrollment through six month follow-up | The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good. |
| A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | From study enrollment through six month follow-up | Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt. |
Secondary
| Measure | Time frame |
|---|---|
| Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | At any point during the study |
Participant flow
Recruitment details
Participants were recruited from 1/2009 - 2/2010 via the internet from an email database of potential enrollees provided by a market research firm. Eligible participants were mailed an informed consent and asked to return a signed copy if they wished to participate. Research staff then made calls to initiate formal study enrollment.
Pre-assignment details
Participants were randomized to treatment group in a 1:1 ratio using a random number generator with block randomization before research staff made calls to initiate formal study enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Practice Quit Attempt Plus Nicotine Replacement Therapy This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. | 426 |
| Practice Quit Attempt Only This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). | 423 |
| Total | 849 |
Baseline characteristics
| Characteristic | Practice Quit Attempt Only | Practice Quit Attempt Plus Nicotine Replacement Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 44 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 389 Participants | 382 Participants | 771 Participants |
| Age Continuous | 50.7 years STANDARD_DEVIATION 11.4 | 50.5 years STANDARD_DEVIATION 11.8 | 50.6 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 423 participants | 426 participants | 849 participants |
| Sex: Female, Male Female | 279 Participants | 266 Participants | 545 Participants |
| Sex: Female, Male Male | 144 Participants | 160 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 179 / 426 | 0 / 0 |
| serious Total, serious adverse events | 0 / 426 | 1 / 423 |
Outcome results
Primary
A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.
Time frame: From study enrollment through six month follow-up
Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Practice Quit Attempt Plus Nicotine Replacement Therapy | A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 185 participants |
| Practice Quit Attempt Only | A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 143 participants |
Comparison: A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.p-value: 0.00495% CI: [1.1, 1.5]Regression, Logistic
Primary
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.
Time frame: From study enrollment through six month follow-up
Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Practice Quit Attempt Plus Nicotine Replacement Therapy | A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 208 participants |
| Practice Quit Attempt Only | A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 168 participants |
Comparison: A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.p-value: 0.00895% CI: [1.1, 1.4]Regression, Logistic
Secondary
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Time frame: At any point during the study
Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Practice Quit Attempt Plus Nicotine Replacement Therapy | Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 82 participants |
| Practice Quit Attempt Only | Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 63 participants |
Comparison: A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.p-value: 0.0995% CI: [1, 1.7]Regression, Logistic
Secondary
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Time frame: At 6-month follow-up
Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Practice Quit Attempt Plus Nicotine Replacement Therapy | Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 68 participants |
| Practice Quit Attempt Only | Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 57 participants |
Comparison: A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.p-value: 0.395% CI: [0.9, 1.6]Regression, Logistic